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Botox

Generic Name: onabotulinumtoxinA (ON a BOT ue LYE num TOX in A)
Brand Names: Botox, Botox Cosmetic


What is Botox?

Botox (onabotulinumtoxinA), also called botulinum toxin type A, ismade from the bacteria that causes botulism. Botulinum toxin blocksnerve activity in the muscles, causing a temporary reduction in muscleactivity.

Botox is used to treat cervical dystonia (severe spasms in the neckmuscles), muscle spasms in the arms and hands, severe underarm sweating(hyperhidrosis) and to prevent headaches in adult patients with chronicmigraine.

Botox is also used to treat certain eye muscle conditions caused bynerve disorders. This includes uncontrolled blinking or spasm of theeyelids, and a condition in which the eyes do not point in the samedirection.

Botox Cosmetic is used to temporarily lessen the appearance of facial wrinkles.

Botox may also be used for other purposes not listed in this medication guide.


Important information about Botox

The botulinum toxin contained in Botox can spread to other bodyareas beyond where it was injected. This has caused seriouslife-threatening side effects in some people receiving botulism toxininjections, even for cosmetic purposes.

Call your doctor at once if you have a hoarse voice, droopingeyelids, vision problems, severe muscle weakness, loss of bladdercontrol, or trouble breathing, talking, or swallowing. Some of theseeffects can occur up to several weeks after a Botox injection.

Botox injections should be given only by a trained medicalprofessional, even when used for cosmetic purposes. Do not seek Botoxinjections from more than one medical professional at a time. If youswitch healthcare providers, be sure to tell your new provider how longit has been since your last Botox injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive Botox if you are allergic to botulinum toxin,or if you have an infection, swelling, or muscle weakness in the areawhere the medicine will be injected.

Before receiving a Botox injection, tell your doctor if you have ALS( Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, abreathing disorder, trouble swallowing, facial muscle weakness, achange in the appearance of your face, seizures, bleeding problems,heart disease, if you have had or will have surgery, or if you haveever received other Botox injections such as Dysport or Myobloc.

The effects of a Botox injection are temporary. Your symptoms mayreturn completely within 3 months after an injection. After repeatinjections, it may take less and less time before your symptoms return,especially if your body develops antibodies to the botulinum toxin.

Before I receive Botox

You should not receive Botox if you are allergic to botulinum toxin,or if you have an infection, swelling, or muscle weakness in the areawhere the medicine will be injected. Tell your doctor if you have everhad a side effect after receiving a Botox in the past.

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

  • myasthenia gravis;

  • Lambert-Eaton syndrome;

  • a breathing disorder such as asthma or emphysema;

  • problems with swallowing;

  • facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);

  • a change in the normal appearance of your face;

  • a seizure disorder;

  • bleeding problems;

  • heart disease;

  • if you have had or will have surgery (especially on your face); or

  • if you have ever received other Botox injections such as Dysport or Myobloc (especially in the last 4 months).

Botox is made from human plasma (part of the blood) which maycontain viruses and other infectious agents. Donated plasma is testedand treated to reduce the risk of it containing infectious agents, butthere is still a small possibility it could transmit disease. Talk withyour doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether Botox will harm anunborn baby. Tell your doctor if you are pregnant or plan to becomepregnant while using Botox. It is not known whether botulinum toxinpasses into breast milk or if it could harm a nursing baby. Do notreceive this medication without telling your doctor if you arebreast-feeding a baby.


How is Botox given?

Botox is injected into a muscle. A doctor, nurse, or otherhealthcare provider will give you this injection. Injections should bespaced at least 3 months apart.

Botox injections should be given only by a trained medical professional, even when used for cosmetic purposes.

Your injection may be given into more than one area at a time, depending on the condition being treated.

While receiving Botox injections for an eye muscle conditions, youmay need to use eye drops, ointment, a special contact lens or otherdevice to protect the surface of your eye. Follow your doctor'sinstructions.

If you are being treated for excessive sweating, shave yourunderarms about 24 hours before you will receive your injection. Do notapply underarm antiperspirants or deodorants for 24 hours before youreceive the injection. Avoid exercise and hot foods or beverages within30 minutes before the injection.

It may take up to 2 weeks after injection before neck muscle spasmsymptoms begin to improve. You may notice the greatest improvement at 6weeks after injection.

It may take only 1 to 3 days after injection before eye muscle spasmsymptoms begin to improve. You may notice the greatest improvement at 2to 6 weeks after injection.

The effects of a Botox injection are temporary. Your symptoms mayreturn completely within 3 months after an injection. After repeatinjections, it may take less and less time before your symptoms return,especially if your body develops antibodies to the botulinum toxin. Donot seek Botox injections from more than one medical professional at atime. If you switch healthcare providers, be sure to tell your newprovider how long it has been since your last Botox injection.

Using Botox more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since Botox has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving Botox?

Botox may impair your vision or depth perception. Be careful if youdrive or do anything that requires you to be able to see clearly.

Avoid using underarm antiperspirants or deodorants for 24 hoursafter a Botox injection if you are being treated for excessive underarmsweating.

Avoid going back to your normal physical activities too quickly after receiving an injection.


Botox side effects

Get emergency medical help if you have any of these signs of anallergic reaction to Botox: hives; difficulty breathing; feeling likeyou might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in Botox can spread to other bodyareas beyond where it was injected. This has caused seriouslife-threatening side effects in some people receiving botulism toxininjections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious sideeffects, some of which can occur up to several weeks after an injection:

  • trouble breathing, talking, or swallowing;

  • hoarse voice, drooping eyelids;

  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

  • loss of bladder control;

  • problems with vision;

  • crusting or drainage from your eyes;

  • severe skin rash or itching;

  • fast, slow, or uneven heartbeats; or

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious Botox side effects may include:

  • muscle weakness near where the medicine was injected;

  • bruising, bleeding, pain, redness, or swelling where the injection was given;

  • headache, muscle stiffness, neck or back pain;

  • fever, cough, sore throat, runny nose, flu symptoms,

  • dizziness, drowsiness, tired feeling;

  • nausea, diarrhea, stomach pain, loss of appetite;

  • dry mouth, dry eyes, ringing in your ears;

  • increased sweating in areas other than the underarms;

  • itchy or watery eyes, increased sensitivity to light; or

  • eyelid swelling or bruising.

This is not a complete list of Botox side effects and others mayoccur. Call your doctor for medical advice about side effects. You mayreport side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Botox?

Other medications such as cold or allergy medicine, muscle relaxers,sleeping pills, bronchodilators, bladder or urinary medicines, andirritable bowel medicines can increase some of the side effects ofBotox. Tell your doctor if you regularly use any of these medications.

Tell your doctor about all other medications you use, especially:

  • an injected antibiotic such as amikacin (Amikin), gentamicin(Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin,Neo-Tab), paromomycin (Humatin, Paromycin), streptomycin, tobramycin(Nebcin, Tobi).

This list is not complete and there may be other drugs that caninteract with Botox. Tell your doctor about all your prescription andover-the-counter medications, vitamins, minerals, herbal products, anddrugs prescribed by other doctors. Do not start a new medicationwithout telling your doctor.


Where can I get more information?

  • Your doctor or pharmacist can provide more information about Botox.

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